Exclusion of ascending/descending aorta and/or aortic arch aneurysm

ABSTRACT

A system and method for exclusion of an aneurysm of an aortic arch region using a graft delivery system capable of maneuvering around an aortic arch, an aortic arch graft, and an occluder system for isolating an aneurysm while occluding one or more corresponding arteries, and with bypass of those arteries being performed using one or more selected bypass grafts. The graft may be branched or branchless. The graft delivery system has a flexible sheath that is manipulated manually with the aid of a guidance system. A hoist delivery system may also be provided. The occluder system may comprise independent occluders with one or more anchor members adjacent to one end. Alternatively, the occluders can be provided as part of the aortic arch graft, either as a built-in singular self-deploying occluder or as built-in multiple occluders. A kit is also provided containing a graft, stents, occluders, and optional delivery system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/347,250, filed on Jan. 14, 2002.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to cardio vascular disease and the treatmentthereof. More particularly, the invention pertains to a method andapparatus for treating an aneurysm of the ascending/descending aortaand/or aortic arch.

2. Description of the Prior Art

By way of background, existing techniques for exclusion of an aneurysmin the ascending/descending aorta and/or the aortic arch require the useof a heart lung machine and drastic reductions in patient bodytemperature, followed by excision and replacement of the diseased aorticarch section. These techniques are associated with a high rate ofcomplications, morbidities, and mortalities. It would be desirable if anexclusion of an aortic arch region could be performed without enteringthe chest or mediastinum, as by use of a transfemoral or otherpercutaneous technique, and preferably requiring only local anesthesiaand sedation.

SUMMARY OF THE INVENTION

The foregoing problems are solved and an advance in the art is obtainedby a novel system and method for the exclusion of an aneurysm of theascending/descending aorta and/or the aortic arch using an aortic archgraft and a graft delivery system capable of maneuvering around anaortic arch. An occluder system may also be provided for occluding oneor more of the left subclavian artery, the left common carotid arteryand the right innominate artery, and with bypass of one or more of thosearteries being performed using selected bypass lumina.

In one embodiment of the invention, the aortic arch graft has branchesand in another embodiment the aortic arch graft is branchless. Thegrafts may be stented or stentless, and they may have various additionalfeatures, such as connection members adapted for use during graftdeployment, for stent restraint, for graft positioning or for otherpurposes.

In one implementation of a branchless aortic arch graft, the aorticgraft has a built-in singular self-deploying occluder that provides theoccluder system. The occluder is preferably sized to be larger than thedistance in an aortic arch between a left subclavian artery and a rightinnominate artery. The occluder may contain an optional support ringsewn internally at the base of the occluder.

In another implementation of a branchless aortic arch graft, the grafthas built-in multiple deployable occluders providing the occludersystem. The occluders are preferably sized to respectively correspond tothe diameters of a left subclavian artery, a left common carotid artery,and a right innominate artery. The occluders can be self-deploying orcan be manually deployed by use of a guide member attached to the top ofeach occluder.

The graft delivery system of the invention may include a flexibletubular sheath surrounding a plunger mechanism, a catheter with a shapedtip, and a flexible guide wire. The sheath preferably has a flexible endthat is capable of bending and maneuvering in any direction, up andaround an artery or vessel. Manipulation of the flexible end can beperformed with the aid of a guidance mechanism running end to end alongthe sheath. The guidance mechanism is adapted to be manipulated manuallyat the distal end of the sheath.

In an alternative implementation of the graft delivery system, ahoisting system is used to introduce the aortic arch graft. The grafthas two or more connection members at one end, which can be attachedwith hoisting elements to an eyelet formed on the flexible guide wire.The hoisting elements and the guide wire extend internally through thegraft. They are used to position the graft in an aortic arch and/orascending/descending aorta by pulling on the hoisting elements afterpositioning the guide wire, and pulling the graft up towards the eyeleton the guide wire.

The occluder system of the invention may include individual occludersadapted to occlude one or more of a left subclavian artery, a leftcommon carotid artery, and a right innominate artery. Each occluder mayhave one or more protruding anchor members adjacent to one end thereof.The anchor members are sized to anchor themselves to the wall of anartery.

The invention further contemplates an aortic arch aneurysm repair kithaving an aortic arch graft, stents, occluders for occluding one or moreof a left subclavian artery, a left common carotid artery, and a rightinnominate artery, and an optimal delivery system.

The invention further contemplates methods for repair of anascending/descending aorta or aortic arch aneurysm. One method is foruse with a branchless aortic arch graft. According to this method, aleft carotid-subclavian bypass between the left common carotid arteryand the left subclavian artery is performed, together with a bilateralfemoral-axillary bypass between the right femoral artery and the rightsubclavian artery, and between the left femoral artery and the leftsubclavian artery. Next, the left subclavian artery, the left commoncarotid artery, and the right innominate artery are occluded proximateto the aortic arch. A branchless aortic arch graft is then introducedvia a percutaneous approach and positioned in the ascending/descendingaorta and/or aortic arch. Another method in accordance with theinvention is for use with a branched aortic arch graft. According tothis method, a left carotid-subclavian bypass between the left commoncarotid artery and the left subclavian artery is performed. Next, theleft carotid artery is occluded proximate to the aortic arch. A branchedaortic arch graft is then introduced via a percutaneous approach andpositioned in the ascending/descending aorta and/or aortic arch andrespective branches.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following more particular description of preferredembodiments of the invention, as illustrated in the accompanyingDrawings, in which:

FIG. 1 is a diagrammatic view showing an outline of the human body and aportion of the circulatory system, and further illustrating a leftcarotid-subclavian bypass, a right femoral-axillary bypass, and a leftfemoral-axillary bypass.

FIG. 2a is a side view of a branchless aortic arch graft of the presentinvention with a built-in self-deploying occluder in a non-deployedcondition;

FIG. 2b is a top view of the graft of FIG. 2a in a non-deployedcondition;

FIG. 2c is a side view of the graft of FIG. 2a in a deployed condition;

FIG. 3a is a side view of an alternate branchless aortic arch graft ofthe present invention with multiple built-in occluders;

FIG. 3b is a top view of the graft of FIG. 3a in a non-deployedcondition;

FIG. 3c is a side view of the graft of FIG. 3a in a deployed condition;

FIGS. 4a and 4 b are cross sectional centerline views of the proximalend of a graft delivery system in accordance with the present inventionin which FIGS. 4a and 4 b show alternative constructions of a sheathintroducer;

FIG. 5 is a perspective view showing the delivery system of FIG. 4adeployed within an aortic arch and advancing into an ascending aorta;

FIG. 6 is a perspective view of the branchless graft of FIG. 2a showingthe graft deployed in an aortic arch;

FIG. 7a is a perspective view of the branchless graft of FIG. 3a showingthe graft deployed in an aortic arch, but prior to deployment ofoccluders;

FIG. 7b is a perspective view of graft of FIG. 3a with occluders beingdeployed using strings in the branches of an aortic arch.

FIGS. 8a and 8 b are perspective views of an alternate delivery systemof the present invention for use with a branched or branchless aorticarch graft with multiple loop connection members at its proximal end,and with the graft being stented and FIGS. 8 a and 8 b respectivelyshowing alternative methods for compressing the stents during graftintroduction;

FIGS. 9a and 9 b are perspective views showing deployment of a modifiedversion of the graft of FIG. 3a using the delivery system of FIG. 8a;

FIG. 10 is a side view of an occluder with integral anchor members;

FIG. 11 is a perspective view showing three occluders according to FIG.10 deployed in the branches of an aortic arch.

FIG. 12 is a diagrammatic view showing an aortic arch, and furtherillustrating a left carotid brachial bypass lumen.

FIG. 13 is a perspective view of a branched aortic arch graft of thepresent invention, and a graft delivery system in accordance with thepresent invention.

FIGS. 14a, 14 b, and 14 c are perspective views of the graft of FIG. 13being prepared for introduction into the delivery system of FIG. 13.

FIG. 15 is a perspective view of the delivery system of FIG. 13 deployedwithin an aortic arch and advancing into an ascending aorta.

FIG. 16 is a two-part perspective view of the graft of FIG. 13 beingdeployed in an ascending aorta.

FIG. 17 is a perspective view of the branches of the graft of FIG. 13being deployed in the branches of an aorta.

FIG. 18 is a perspective view of the graft of FIG. 13 being secured withstents in an aortic arch region and the branches of an aorta.

FIG. 19 is a perspective view of the graft of FIG. 13 secured in anaortic arch region and branches of an aorta and the delivery system ofFIG. 13 being removed.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

A. Introduction

The system and method of the invention will now be described by way ofexemplary embodiments shown by the drawing figures, in which likereference numerals indicate like elements in all of the several views.The terms distal and proximal are used herein and will be understood toindicate position relevant to the heart, with proximal indicating aposition closer to the heart and distal indicating a position fartheraway from the heart.

As summarized above, the invention represents a departure from theconventional techniques for repairing an aneurysm of the aortic arch orascending/descending aorta in which the diseased section is excised andreplaced. The invention contemplates the insertion of the aortic archgraft to isolate the diseased section from blood flow. This presents achallenge because the aortic arch has three branches connected to theleft subclavian artery, left common carotid artery and a rightinnominate artery. The present invention proposes two solutions, onebeing the use of an aortic arch graft with branches and the other beingthe use of a branchless aortic arch graft with occlusion of the aorticbranches.

B. Branchless Aortic Arch Graft

As indicated, one solution to the aortic arch repair challenge is toimplant a branchless aortic arch graft without cutting off blood supplyto the arteries leading from the aortic branches. This is can be done byperforming an arterial bypass procedure prior to graft introduction, asshown in FIG. 1. First and second surgical teams using arterial bypassgrafts 2 can implement the bypass procedure. The bypass grafts areconventional in design and material and may be of the same type used forfemoral-axillary bypass procedures. A first surgical team performs aleft carotid-subclavian bypass 5, in which a bypass graft 2 is placedbetween the left carotid artery 6 and the left subclavian artery 8. Asecond surgical team performs a bilateral femoral-axillary bypass 7 inwhich bypass grafts 2 are respectively placed between the rightsubclavian artery 4 and the right femoral artery and between the leftsubclavian artery 8 and the left femoral artery. The left common carotidartery 6, left subclavian artery 8, and right innominate artery 9 maythen be occluded proximate to an aortic arch either prior to or part ofthe graft deployment procedure.

Following the bypass procedure, an aortic arch graft can be deployed inthe aortic arch and/or ascending aorta to exclude the aneurysm, followedby occlusion of the branches of the aortic arch. FIGS. 2a and 2 b showan exemplary branchless aortic arch graft 10 that may be used for thispurpose. The graft 10, which can be constructed of dacron or othersuitable biocompatible material, has a tubular shape when in itsexpanded state and is capable of being folded or twisted for loadinginto a sheath introducer (See FIGS. 4a and 4 b). The graft 10 has afirst open end 18 and second open end 19. Each end may have a stent 12mounted thereto by sewing or the like. Alternatively, stents may beinserted following graft deployment. The graft 10 further includes asingle self-deploying occluder 14. The occluder 14 is preferably madefrom additional graft material that is sewn or otherwise attached to thewall of the graft 10. Sufficient material is used so that the occluder14 is capable of deploying laterally outward beyond the nominal tubularshape of the graft 10. The occluder 14 is preferably elliptical inshape, but other shapes could be used. It extends along the partiallength of the graft 10 and is preferably sized to be larger than thedistance in an aortic arch between a left subclavian artery and a rightinnominate artery. An opening is formed in the wall of the graft 10 thatallows blood to flow into the occluder 14 from the main body of thegraft (see below). A support ring 13 may be provided at a base 17 of theoccluder 14 to help define the opening. The support ring 13 can be madeof nitonol and is preferably 1-2 mm larger than the base 17 of theoccluder 14. As described in more detail below relative to FIG. 6, thegraft 10 can be positioned by using one or more iodinated radio-opaquemarkers 15.

In FIG. 2c, the occluder 14 of the graft 10 is seen from a side view ina deployed state. Deployment occurs as blood flow 16 forces the wall ofthe occluder 14 to move laterally beyond the girth of the graft 10.

The stents 12 can be formed as conventional spring stent members madefrom a shape memory material such as nitonol (nickel-titanium alloy)that self deploy upon insertion. Alternatively, they may be formed asnon-self deploying stents. In either case, the stents 12 must be sizedfor use in the ascending/descending aorta or aortic arch. Note that onlytwo stents are desirable because of the curved shape of the aortic arch.

Turning to FIGS. 3a and 3 b, another embodiment of an aortic arch graft20 is similar in construction to the graft 10, but is provided withmultiple occluders 24 instead of a single occluder. The occluders 24 mayinclude loop members 26 located externally at the end of each occluder24. The loop members 26 may be closed or partially open such thatstrings/filaments or other occluder deployment members 28 may bethreaded or otherwise attached for manual deployment of the occluders24. FIG. 3c shows a side view of the graft 20 with the occluders 24 in adeployed state. By way of example only, the strings 28 can be threadedthrough loop members 26 and pulled to expand the occluders 24 from themain body of the graft 20. In an alternative construction, the occluders24 can be adapted to be self-deployable by virtue of blood flow 27. Asdescribed in more detail below in FIG. 6, the graft 20 is positionedusing iodinated radio-opaque markers 29.

Turning now to FIG. 4a, a delivery system 40 for positioning any of theaortic graft assemblies herein includes a sheath introducer 42surrounding a plunger assembly 45, which itself surrounds a catheter 50.The sheath introducer 42, which can be made from biocompatible plasticor any other biocompatible, substantially flexible material, is agenerally tubular member with a proximal end 43 and distal end (notshown), each end being provided with an opening. To provide theflexibility required to negotiate the aortic arch, the sheath 42 can beconstructed with flexible ribs 60 running from the proximal end 43 downthe shaft of the sheath introducer about one to three inches. By way ofexample only, the flexible ribs 60 can be configured as shown in theinset of FIG. 4a. The plunger assembly 45 is of standard construction.It includes a central lumen 44 for passage over the catheter 50, and aplunger head 46 located at the most proximal part of the plungerassembly. The plunger head 46 preferably has a substantially flatproximal surface for contacting a graft assembly as described herein sothat the plunger assembly 45 is able to push the graft in a proximaldirection relative to the sheath introducer 42 during graft deployment.The catheter 50 is substantially tubular with two hollow interiorpassages 51 and 53. A proximal end of the catheter 50 is equipped with ahydraulic inflatable tip 54 that is adapted to be filled with a liquid58, preferably saline. A suitable injection device, such as anattachable syringe 47, is used to force solution up through thehydraulic passage 51 of the catheter 50 and into the catheter tip 54.The catheter passage 53 is conventionally adapted to receive a guidewire 56 to direct the delivery system 40 through appropriate arteries aspart of a transfemoral approach.

An optional internal guidance mechanism 55 can be provided to enable theproximal end 43 of the sheath 42 to bend and maneuvermulti-directionally, up and around an artery or vessel. The guidancemechanism 55 can be implemented in a variety of ways, but is shown byway of example only in FIG. 4a as including a wire/filament 57 attachedto the proximal end 43 of the sheath 42. The wire/filament 57 runs endto end along the inside of the sheath 42, and is activated manually atthe distal end thereof. If desired, a suitable control device, such as aknob or lever (not shown) could be attached to allow manipulation of thewire/filament 57.

FIG. 4b illustrates an alternative way in which a sheath introducer canbe constructed with the required flexibility to allow its use in thedelivery system 10. In particular, a sheath introducer 58 is formed witha hollow wall 59 that is adapted to be filled with a liquid, preferablysaline, to provide various states of rigidity by controlling thehydraulic pressure within the wall 59. A suitable injection device, suchas an attachable syringe 47, is used to force solution up through thewall 59 of the sheath introducer 58 until the sheath introducer 58 is ofa desired rigidity. Note that all other structure shown in FIG. 4b isidentical to that shown in FIG. 4a, and its description will not berepeated.

The delivery system 40 can be used to deploy an aortic arch graft (suchas the grafts 20 and 40) according to the following procedure: Afteropening a femoral artery (right or left), the guide wire 56 is insertedtherein and passed through the descending aorta, around the aortic arch,through the ascending aorta, and into the aortic valve of the heart.Note that the guide wire 56 has a relatively blunt tip so that it doesnot damage any blood vessel walls. Next, the proximal end of thecatheter 50 of the delivery system 40 is inserted over the distal end ofthe guide wire 56. The delivery system 40 will have been previouslyloaded with an aortic arch graft inside of the sheath introducer 42.After inflating the catheter tip 54 with the liquid to a desiredpressure, the delivery system 40 is inserted into the femoral artery andpassed through the descending aorta 61, the aortic arch 62, and into theascending aorta 64 as depicted in FIG. 5. As the catheter tip 54 reachesthe aortic arch 62, the guidance mechanism 55 (if present) is used tobend the sheath introducer 42 (or 58) to direct the delivery system 40to the ascending aorta 64, where it is positioned using iodinatedradio-opaque markers on graft. With the delivery system 40 in position,the graft 65 is deployed from the sheath introducer 42 (or 58) using theplunger 45. With the proximal end of the graft sufficiently secured tothe vessel wall by virtue of its proximal stent, the sheath introducer42 (or 58) is withdrawn from the ascending aorta 64 and the descendingaorta 61 as the plunger 45 simultaneously deploys the remaining lengthof the graft around the aortic arch 62 and down to the descending aorta61. With the distal end of the graft sufficiently secured in position byvirtue of its distal stent, the catheter tip 54 is deflated and pulledthrough the interior of the graft until it reaches the proximal end ofthe sheath introducer 42 (or 58). The delivery system 40 is then removedfrom the body, followed by the removal of the guide wire 56.

If the delivery system 40 is used to implant the aortic arch graft 10 ofFIG. 2a, the implantation procedure described above will result in thegraft 10 being deployed in the aortic arch in the manner shown in FIG.6. As blood flows through the graft 10, (shown at 16) the wall of thesingle occluder 14 will be forced laterally outward by the force of theblood flow 16 at least the distance between the right innominate artery92 and left subclavian artery 94. Due to pressure differential, thisforce will be greater than the force asserted from blood flow within theoccluded arteries. The occluder 14 will thus be retained in position.

If the delivery system 40 is used to implant the aortic arch graft 20 ofFIG. 3a, the implantation procedure described above will result in thegraft 10 being deployed in the aortic arch in the manner shown in FIGS.7a and 7 b. Although the graft 20 is introduced in the manner describedabove relative to FIG. 5, delivery of this type of graft includes theadditional step of temporarily attaching occluder deployment members,such as strings/filaments 101, to the occluders 24 before the graft 20is loaded into the sheath introducer 42 (or 58). The strings/filaments101 can be respectively inserted into the right innominate artery, leftcarotid artery, and left subclavian artery and pulled from their pointof entry, passed through the descending aorta, into the femoral artery,and out of the vessel at the groin. Next, the strings/filaments 101 aretemporarily attached to the loop members 26 of the correspondingoccluders 24 of the graft 20. The graft 20 is then loaded into thesheath introducer 42 (or 58). As the delivery system 40 is inserted intothe femoral artery and advanced for positioning in the aortic arch 64,the strings/filaments 101 are simultaneously pulled, remainingrelatively taut and forward of the delivery system 40 to prevententanglement within the arterial vessels. FIG. 7a shows the graft 20 inposition and ready for the occluders 24 to be deployed by way of a finalpulling of the strings/filaments 101 temporarily attached to the loopmembers 26. One at a time (or simultaneously), the attachedstrings/filaments 101 are pulled to assist movement of the occluders 24up into a corresponding artery 106, blocking blood flow and occludingthe artery as seen in FIG. 7b. Because the force of the blood flow 27within the graft 20 is greater than the force being asserted from bloodflow 109 within the occluded arteries 106 the occluders 24 will remainin a deployed state. After the occluders 24 are sufficiently secured,the strings/filaments 101 are detached from the loop members 26 of theoccluders 24 by pulling one end until the opposing end is fullywithdrawn from the body. Although not shown, a modified version of thegraft 20 wherein the occluders 24 do not have loop members 26 and arenot deployed with strings/filaments 101 could also be used. In thisinstance, the occluders 24 would be deployed by the blood flow 27 alone,which forces the occluders 24 to expand out from the graft 20 and intoposition in the arteries 106, which are thereby occluded. The occluders24 will then remain in a deployed state due to blood flow pressuredifferential, as described above. Alternatively, each occluder 24 couldbe stabilized with a stent (not shown).

Turning now to FIGS. 8a and 8 b, an alternate delivery system 200featuring a graft hoisting arrangement can be used to position an aorticarch graft 202 in an ascending/descending aorta and/or an aortic arch.The delivery system 200 includes a flexible guide wire or catheter 204,made of plastic or other suitable material, with an eyelet 206 at ornear its proximal end 207 (which is preferably blunt tipped), andhoisting elements, such as strings 208. The graft 202 includes a firstopen proximal end 210 and second open distal end 212, each end having astent 214 mounted thereto by sewing or the like. Alternatively, stentsmay be inserted following graft deployment. The graft 202 can beconstructed with one or more occluders, as shown in FIGS. 9a and 9 b,which depict the graft 202 in a deployed position. With or withoutoccluders, the graft 202 is constructed with two or more loop members216 (or other suitable attachment elements) at the proximal end 210thereof. To deploy the delivery system 200, the strings 208 aretemporarily threaded through the loop members 216 and through the eyelet206 of the guide wire 204. Both the strings 208 and the guide wire 204are placed internally through the graft 202 and out the distal end 212of graft 202. Either prior to or after the foregoing threadingprocedure, the graft 202 is inserted into a proximal end 218 of a verythin-walled sheath introducer 219 by radially compressing the stents 214(if present). The graft 202 will remain seated in the sheath introducer219 by virtue of the radial outward force imparted by the stents 214. Assuch, the sheath introducer 219 should be made of a material that iscapable of resisting the expansive pressure of the compressed stents214, yet should also have good bending compliance. Contemplatedmaterials include very thin-walled polypropylene or polyethylene sheetstock e.g. having a thickness of about 1-5 mil. which will act as anouter skin-like barrier and stent retainer for the graft untilplacement. This arrangement is shown in FIG. 8a.

After the delivery system 200 is readied for deployment in theabove-described manner, the proximal end 207 of the guide wire 204 isinserted into the femoral artery. It is advanced to the descendingaorta, around the aortic arch, and then to the ascending aorta where theeyelet 206 of the guide wire 204 is positioned using an imaging device,such as an image amplifier, such that the proximal end 207 enters theaortic valve. The attached strings 208 are allowed to continuously passthrough the loop members 216 of the graft 202 so that the graft 202 andthe sheath introducer 219 remain in a stable position outside of thebody during insertion and positioning of the guide wire 204 in theascending aorta. With the guide wire 204 in position, the sheathintroducer 219 with the graft 202 installed therein is inserted into thefemoral artery. The guide wire 204 is held in constant position as thestrings 208 are pulled. This movement of the strings 208 causes thesheath introducer 201 and the graft 202 to be hoisted towards the eyelet206 of the guide wire 204. This moves the sheath introducer 219 and thegraft 202 through the femoral artery, up to the descending aorta, aroundthe aortic arch, and into the ascending aorta, until they are properlypositioned. The sheath introducer 219 is then separated from the graft202 and removed by pulling on its distal end while holding the strings208 to keep the graft 202 in position. As the sheath introducer 219 isremoved, the graft 202 is revealed, thus allowing stents 214 (ifpresent) to expand and secure the graft 202 in position. After thesheath introducer 201 is completely removed, the strings 208 aredetached from the loop members 203 of the graft 202 and the eyelet 206of the guide wire 204 by pulling one end of each string until theopposing end is fully withdrawn from the body. After the strings 208 areremoved, the guide wire 204 is also removed from the body.

FIG. 8b shows how the delivery system 200 in FIG. 8a can be used with analternate aortic arch graft 251 and without a sheath introducer 219. Thealternate graft 251 includes multiple loop members 252 placed around theoutside of the graft and positioned near the center of expandable stents254. Before deployment of the graft 251 in a body, the stents 254 arewrapped tightly by stent retaining members such as filament/strings 256,causing them to compress. Other stent retaining members, such assprings, could also be used. With the stents 254 in a compressed state,the filament/strings 256 are tied in a releasable slipknot 258 or thelike, with its remaining length running along the outside of graft 251.The graft 251 is positioned in the aortic arch using the hoisting methodas described above in FIG. 8a. The stents 254 are released by pullingone end of the filament/strings 256 until the slipknot 258 is released,thus allowing the stents 254 to expand. The filament/strings are thendetached from the loop members 252 by pulling one end of each stringuntil the opposing end is fully withdrawn from the body.

As previously stated, FIGS. 9a and 9 b show how a modified version 220of the aortic arch graft 20 of FIG. 3a can be deployed using thedelivery system 200. The modification refers to the fact that themodified version 220 has loop members on its proximal end for hoisting.It should be noted that the guide wire 204 and the strings 208 couldalso be used to hoist a stentless version of the graft 202 with orwithout the use of the sheath introducer 219. In that case, stents wouldbe inserted to secure the graft following its deployment in the aorticarch region.

Turning to FIGS. 10 and 11, an exemplary occluder 300 is shown for usewith a tubular aortic arch graft 302 that has no integral occluders. Theoccluder 300 has a tubular shape when in its expanded state and iscapable of being folded or twisted for loading into a sheath introducer,such as the introducer 42 (or 58) of FIGS. 4a and 4 b. The occluder 300can be constructed of a suitable stent graft material, such as dacron.As shown in FIG. 10, the occluder 300 has a first closed (proximal) end304 and a second closed (distal) end 305, with each end having a stent308 secured thereto by sewing or the like. Alternatively, a single stentcould be used. The occluders 300 are of a size to adequately block bloodflow through an aortic arch artery when positioned therein. The occluder300 further includes one or more (two are shown) integral anchor members310, such as spikes, at one end thereof. The anchor members 310 arepreferably sized to be long enough to enter the wall of an arterywithout piercing through the wall. FIG. 11 shows the positioned graft302 in an aortic arch and three occluders 300 with anchor members 310respectively positioned in the right innominate artery 314, the leftcarotid artery 316 and the left subclavian artery 318. The anchormembers 310 are located at the proximal ends 304 of the occluders 300and are anchored in the arterial walls 325. The occluders 300 may beintroduced and properly positioned in accordance with a delivery systemas seen in FIGS. 4a or 4 b, using carotid and subclavian approaches.Note that the three occluders 300 and the graft 302 shown in FIGS. 10and 11 can be provided in kit form for use by a medical practitioner toexclude an aortic arch aneurysm. The kit could further include a sheathintroducer as shown in FIGS. 4a or 4 b.

C. Branched Aortic Arch Graft

As indicated, one solution to the aortic arch repair problem is toimplant a branched aortic arch graft without cutting off blood supply tothe arteries leading from the aortic branches. Preferably, to avoidpossible complications associated with deploying a branch using acarotid approach, the graft will only have two branches, one for theright innominate artery and the other for the left subclavian artery. Assuch, the left common carotid artery will be blocked from blood supply.Therefore, a carotid-subclavian bypass procedure and an occlusion of theleft common carotid artery proximate to the aortic arch must be done toreintroduce blood flow to the left common carotid artery prior to graftintroduction, as shown in FIG. 12. The entire exclusion operation,including bypass and graft deployment procedure, can be implemented bytwo teams of surgeons. A first surgical team performs a leftcarotid-subclavian bypass, in which a bypass graft 402 is placed betweenthe left carotid artery 406 and the left subclavian artery 422. This isfollowed by an occlusion of the left common carotid artery 406 proximateto an aortic arch 408 by tying 410 or use of an occluder (see FIG. 10).A second surgical team exposes a femoral artery (not shown in FIG. 12)and a right brachial artery 430 and a left brachial artery 431 (see FIG.13). The second surgical team introduces a guide wire 414 a through afemoral artery, to the descending aorta 418, and around the aortic archto the ascending aorta 419. Similar procedures are performed relative tothe two non-occluded aortic branches. Guide wire 414 b is introducedthrough a femoral artery to the descending aorta 418, to the rightinnominate/right subclavian artery 420 and to the opening previouslyexposed in the right brachial artery 430. A guide wire 414 c isintroduced through a femoral artery to the descending aorta 418, to theleft subclavian artery 422, and to the opening previously exposed in theleft brachial artery 431. The second surgical team introducesdeployments members such as strings/filaments 415 through the body tothe openings in the right and left brachial arteries 430 and 431 usingthe same procedure as described above for the guide wires 414 b and 414c. The guide wires 414 a-c and strings/filaments 415 may all then bepassed through a sheath introducer 460 so that the strings/filaments 415can be attached to corresponding parts of a branched aortic arch graft440 and the guide wires 14 a-c can be used to guide the delivery systemwith the graft, as will now be described.

Turning to FIG. 13, a branched aortic arch graft 440 is shown with adelivery system 442 for positioning the graft 440. As indicated above,the graft 440 is constructed with two branches 444, one for the rightinnominate artery the other for the left subclavian artery. The graftmay also have loop members 447 at a proximal end 450. The loop members447 may be closed or partially open such that deployment members, suchas strings/filaments 452 may be threaded or otherwise attached for thepurpose of closing the proximal end 450 during graft deployment, asdescribed below. The branches 444 each have an open ends 448. The end448 may have loop members 447 mounted thereon so that strings/filaments415 may be threaded or otherwise attached for the purpose of closing theopen ends 448 during graft deployment. The delivery system 442 comprisesa sheath introducer 460 and a catheter 462. The catheter 462 includes atip 464 and first and second proximal expandable portions 466 and 468.

With reference now to FIGS. 14a, 14 b, and 14 c, loading of the graft440 into the sheath introducer 460 is shown. First, the guide wires 414a-c and the strings 415 are passed through a sheath introducer 460 (seeFIG. 14c). Next, a non-self deploying stent 469 is placed around thesecond proximal expandable portion 468 of the catheter 462 as seen inFIG. 14a. FIG. 14b shows the guide wires 414 b and 414 c from thebrachial arteries placed through the open ends 448 of the branches 444of the graft 440. FIG. 14b also shows the guide wire 414 a from theascending aorta being passed through the tip 464 of catheter. Next, thestrings/filaments 415 are threaded through the loop members 447 at thedistal ends of the branches 444 of the graft 440 and secured (e.g. witha releasable slipknot), and a string/filament 452 is threaded throughthe loop members 447 at the proximal end of the graft 440. The graft 440is then placed over the catheter 462 until its proximal end reaches thefirst proximal expandable portion 466. FIG. 14c shows the next stepwhere the string/filament 452 is pulled tightening the proximal end ofthe graft 440 around the proximal expandable portion 466 of the catheter462. As shown in FIG. 14c, the catheter 462 and the graft 440 are thenslid into the sheath introducer 460 until the catheter tip 464 reachesthe proximal end of the sheath introducer 460.

FIG. 15 shows the sheath introducer 460, loaded as depicted in FIG. 14cfollowing advancement into the aortic arch 408. This can be done in themanner described above by inserting the loaded sheath introducer 460into the open femoral artery, passing it through the descending aorta418, and then around the aortic arch 408 into the ascending aorta 419.

Turning to FIG. 16 and FIG. 17, the graft 440 is extracted from thesheath 460. Note that the first proximal expandable portion 466 of thecatheter 462 is expanded tightly against the proximal end of the graft440, which is closed by maintaining tension on the string/filament 452threaded through the loop members 447. The graft 440 is pushed out ofthe sheath introducer 460 and into the ascending aorta 419 by proximallyadvancing the catheter 462 relative to the sheath introducer 460. Whenthe graft 440 is in a desired position, the string/filament 452 isreleased and the first proximal expandable portion 466 of the catheter462 is expanded until the graft 440 is tight against an arterial wall.This temporarily secures the graft 440 as the sheath introducer 460 ispulled down the descending aorta 418 until the graft 440 is fullyexposed. Next, each branch 444 of the graft 440 is positioned into theirrespective aortic branch by pulling on the distal ends of thestrings/filaments 415 threaded through the loop members 447 of thebranch 444.

As shown in FIG. 18, with the graft 440 in position, the first proximalexpandable portion 466 of the catheter 462 is deflated. The catheter 462is pushed further until the second most proximal expandable portion 468of the catheter 462 with the stent 469 is positioned at the end of theproximal end of the graft 440. The second proximal expandable portion468 is then expanded, causing the stent 469 to open and secure theproximal end of the graft 440. The stent 469 may also be self-releasing,expanding as it is released from the sheath introducer 460. The branches444 of the graft 440 are then secured in their respective aorticbranches and the distal end 477 of the graft 440 in similar fashion aswill now be described.

With reference to FIGS. 18 and 19, the branches of the graft aredeployed using the same procedure as described above for the main bodyof the graft. The guide wires 414 b and 414 c are each passed throughthe catheter tip 503 of a respective delivery system 502. One ofdelivery systems 502 is then inserted into the open right brachialartery until it reaches the branch 444 a of the graft 440 in a rightinnominate artery. The other delivery system 502 is inserted into theopen left brachial artery until it reaches the branch 444 b of the graft440 in a left subclavian artery. Catheters 504 are pushed until thesecond most proximal expandable portions 505 thereof, each carrying astent 508, are respectively positioned at the distal end of the branches444 a and 444 b. The second proximal expandable portions 505 of eachcatheter 504 are then expanded causing the stents 508 to open and securethe respective distal end of the branches 444 a and 444 b. The deliverysystems 502 are then removed from the body. Then, with the graft 440secured by stents 469 and 508, the sheath introducer 460 is removed fromthe body, along with the strings/filaments 415 and 452, and the guidewires 414 by pulling on the distal ends.

Accordingly, a system and method for exclusion of an aneurysm of theascending/descending aorta and/or the aortic arch have been disclosed.While various embodiments of the invention have been shown anddescribed, it should be apparent that many variations and alternativeembodiments could be implemented in accordance with the teachingsherein. It is understood, therefore, that the invention is not to be inany way limited except in accordance with the spirit of the appendedclaims and their equivalents.

What is claimed is:
 1. A method for exclusion of an aneurysm of anaortic arch region, comprising: introducing via a percutaneous approachan aortic arch graft into an aortic arch region such that a proximal endof said graft lies proximate an ascending aorta above an aortic cusp anda distal end lies below a left subclavian artery; and retaining saidaortic arch graft in position by way of stenting; said aortic arch graftbeing introduced via a delivery system comprising a sheath introduceradapted for deployment around an aortic arch; said sheath introducercomprising an internal guidance mechanism capable of multi-directionalmaneuvering; and said sheath introducer further comprising a complianttip section comprising one or more flexible ribs.
 2. A method forexclusion of an aneurysm of an aortic arch region, comprising:introducing via a percutaneous approach an aortic arch graft into anaortic arch region such that a proximal end of said graft lies proximatean ascending aorta above an aortic cusp and a distal end lies below aleft subclavian artery; and retaining said aortic arch graft in positionby way of stenting; said aortic arch graft comprising multiple loopmembers at one end and said introducing step includes attaching saidloop members via hoisting elements to a flexible guide wire having aneyelet, passing said hoisting elements and said guide wire internallyinto said graft, and hoisting said graft into position by pulling onsaid hoisting elements; said aortic arch graft comprising a stent ateach end of said graft, and said introducing step includes compressingsaid stents with releasable retaining members that are releasable from alocation outside of a patient's body; and said retaining memberscomprising elements selected from the group consisting of filaments andstrings.
 3. A method for exclusion of an aneurysm of an aortic archregion, comprising: introducing via a percutaneous approach an aorticarch graft into an aortic arch region such that a proximal end of saidgraft lies proximate an ascending aorta above an aortic cusp and adistal end lies below a left subclavian artery; and retaining saidaortic arch graft in position by way of stenting; said aortic arch graftcomprising multiple loop members at one end and said introducing stepincludes attaching said loop members via hoisting elements to a flexibleguide wire having an eyelet, passing said hoisting elements and saidguide wire internally into said graft, and hoisting said graft intoposition by pulling on said hoisting elements; and said hoistingelements comprising elements selected from the group consisting offilaments and strings.
 4. A method for exclusion of an aneurysm of anaortic arch region, comprising: introducing via a percutaneous approachan aortic arch graft into an aortic arch region such that a proximal endof said graft lies proximate an ascending aorta above an aortic cusp anda distal end lies below a left subclavian artery; retaining said aorticarch graft in position by way of stenting; and performing one or moreof: a left carotid-subclavian bypass by placing a bypass graft between aleft common carotid artery and a left subclavian artery; a bilateralfemoral-axillary bypass by placing a first bypass graft between a leftfemoral artery and a left subclavian artery and a second bypass graftbetween a right femoral artery and a right subclavian artery; andoccluding one or more of said left subclavian artery, said left commoncarotid artery and a right innominate artery proximate to an aorticarch.
 5. A method in accordance with claim 4 wherein said aortic archgraft is introduced via a delivery system comprising a sheath introduceradapted for deployment around an aortic arch.
 6. A method in accordancewith claim 5 wherein said sheath introducer comprises an inflatabletubular wall.
 7. A method in accordance with claim 5 wherein said sheathintroducer comprises an internal guidance mechanism capable ofmulti-directional maneuvering.
 8. A method in accordance with claim 7wherein said sheath introducer comprises a compliant tip section.
 9. Amethod in accordance with claim 5 wherein said delivery system comprisesa catheter equipped with a hydraulic inflatable tip.
 10. A method inaccordance with claim 5 wherein said aortic arch graft has multiple loopmembers at one end, said delivery system includes a catheter havingmultiple expandable portions at its proximal end, and said loop membersare adapted for receiving deployment members for deploying and temporarypositioning of said graft prior to stenting.
 11. A method in accordancewith claim 5 wherein said aortic arch graft comprises multiple loopmembers at one end and said introducing step includes attaching saidloop members via hoisting elements to a flexible guide wire having aneyelet, passing said hoisting elements and said guide wire internallyinto said graft, and hoisting said graft into position by pulling onsaid hoisting elements.
 12. A method in accordance with claim 11 whereinsaid aortic arch graft comprises a stent at each end of said graft andwherein said introducing step includes inserting said graft into asheath introducer that comprises a flexible thin-walled sheath, saidsheath introducer being made of a material capable of resisting theexpansive pressure of a compressed stent.
 13. A method in accordancewith claim 11 wherein said aortic arch graft comprises a stent at eachend of said graft, and said introducing step includes compressing saidstents with releasable retaining members that are releasable from alocation outside of a patient's body.
 14. A method in accordance withclaim 13 wherein said aortic arch graft comprises multiple loop membersaround an outside portion of said graft and positioned near said stents,said loop members being adapted to retain said retaining members inposition.
 15. A method in accordance with claim 4 wherein said aorticarch graft is branchless and said bypass step includes: performing aleft carotid-subclavian bypass by placing a bypass graft between a leftcommon carotid artery and a left subclavian artery; performing abilateral femoral-axillary bypass by placing a first bypass graftbetween a left femoral artery and a left subclavian artery and a secondbypass graft between a right femoral artery and a right subclavianartery; and occluding said left subclavian artery, said left commoncarotid artery and a right innominate artery proximate to an aorticarch.
 16. A method in accordance with claim 15 wherein said aortic archgraft is branched and said bypass step includes: performing a leftcarotid-subclavian bypass by placing a bypass graft between a leftcommon carotid artery and a left subclavian artery; and occluding saidleft common carotid artery proximate to an aortic arch.
 17. A method inaccordance with claim 15 wherein said introducing step includesintroducing an aortic arch graft with a built-in single self-deployingocciuder via a femoral approach into said aortic arch such that saidoccluder faces and fills with blood to occlude said left subclavianartery, said left common carotid artery and a right innominate artery.18. A method in accordance with claim 15 wherein said introducing stepincludes introducing an aortic arch graft with built-in multipleself-deploying occluders via a femoral approach into said aortic archsuch that said occluders face and fill with blood to respectivelyocclude said left subclavian artery, said left common carotid artery anda right innominate artery.
 19. A method in accordance with claim whereinsaid introducing step includes introducing occluder guide members via aleft subclavian artery, a left common carotid artery and a rightinnominate artery, passing said guide members via a descending aorta toa femoral artery, attaching said guide members to corresponding ones ofsaid occluders, introducing said aortic arch graft via a femoralapproach into said aortic arch, and occluding said left subclavianartery, said left common carotid artery and a right innominate arteryproximate to an aortic arch with deployment of said occluders bymanipulation of said guide members.
 20. A method in accordance withclaim 19 wherein said occluder guide members are elements selected fromthe group consisting of filaments and strings.